← Back to Search

Prosthetic Valve

TAVI for Prosthesis Failure

N/A

Waitlist Available

Led By Josep Rodés-Cabau, MD

Research Sponsored by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Small (≤23mm) surgical valve

Stented surgical valves

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial found that TAVI can be a safe and effective treatment for patients with small surgical bioprostheses, with low rates of transvalvular residual gradients and PPM.

Who is the study for?

This trial is for patients with small (≤23mm) surgical aortic bioprostheses that are not working well, specifically those with severe stenosis or regurgitation. Candidates must have previously received a stented valve and be approved for a valve-in-valve (ViV) procedure by the Heart Team. Patients with stentless or sutureless valves cannot participate.Check my eligibility

What is being tested?

The LYTEN trial is comparing two types of heart valve replacement procedures using different brands of valves: the balloon-expandable Edwards Valve and the self-expandable CoreValve system, in patients whose previous surgical bioprosthesis has failed.See study design

What are the potential side effects?

Potential side effects from these TAVI_ViV procedures may include risks associated with heart valve surgery such as bleeding, blood vessel complications, irregular heart rhythms, stroke, infection, and issues related to how the new valve fits and functions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My surgical valve is 23mm in size or smaller.

Select...

I have a stented valve from heart surgery.

Select...

My heart valve replacement is not working properly and I've been approved for a valve-in-valve procedure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of prothesis-patient mismatch (PPM) (valve performance)

Residual transvalvular gradient

Secondary outcome measures

Changes in LV hypertrophy

Clinical safety endpoints

Combined endpoints: Moderate-severe AR or severe PPM at 1-year follow-up.

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: SAPIENExperimental Treatment1 Intervention

Following the Heart Team's decision to proceed with a TAVI-ViV procedure, patients will received an Edwards (SAPIEN XT or SAPIEN 3) valve.

Group II: COREVALVEExperimental Treatment1 Intervention

Following the Heart Team's decision to proceed with a TAVI-ViV procedure, patients will received the CoreValve Evolut R or Evolut PRO valve system.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de QuebecLead Sponsor

36 Previous Clinical Trials

9,640 Total Patients Enrolled

Josep Rodés-Cabau, MDPrincipal InvestigatorInstitut universitaire de cardiologie et de pneumologie de Québec, University Laval

5 Previous Clinical Trials

1,760 Total Patients Enrolled

1 Trials studying Prosthesis Failure

310 Patients Enrolled for Prosthesis Failure

Media Library

CoreValve Evolut R or Evolut PRO System (Prosthetic Valve) Clinical Trial Eligibility Overview. Trial Name: NCT03520101 — N/A

Prosthesis Failure Research Study Groups: SAPIEN, COREVALVE

Prosthesis Failure Clinical Trial 2023: CoreValve Evolut R or Evolut PRO System Highlights & Side Effects. Trial Name: NCT03520101 — N/A

CoreValve Evolut R or Evolut PRO System (Prosthetic Valve) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03520101 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available openings for individuals who are interested in joining this trial?

"Per clinicaltrials.gov, this investigation is not presently recruiting study participants. It first appeared on May 10th 2017 and was last updated in July 12th 2022. Though this trial isn't currently accepting patients, there are 189 other trials actively seeking volunteers."

Answered by AI

What key outcomes is this trial aiming to achieve?

"This trial, assessed over a 30-day time frame, is aiming to evaluate the Rate of prothesis-patient mismatch (PPM) relative to valve performance. Secondary objectives include assessing Moderate or severe PPM moderate-severe AR at both 30 days and 1 year; Exercise capacity as evaluated by the six-minute walk test; and Combined endpoints: Moderate-severe AR or severe PPM at 1-year follow up."

Answered by AI

Recent research and studies

Journal of the American College of CardiologyJournal

Balloon- Vs Self-expanding Valve Systems for Failed Small Surgical Aortic Valve Bioprostheses

Rodés-Cabau, Josep, Amr E. Abbas, Vicenç Serra, Victoria Vilalta, Luis Nombela-Franco, Ander Regueiro, Karim M. Al-Azizi, et al.. 2022. “Balloon- Vs Self-expanding Valve Systems for Failed Small Surgical Aortic Valve Bioprostheses”. Journal of the American College of Cardiology. Elsevier BV. doi:10.1016/j.jacc.2022.05.005.

Journal of the American College of CardiologyJournal

Balloon- Vs Self-expanding Valve Systems for Failed Small Surgical Aortic Valve Bioprostheses

clinicaltrials.govStudy

Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprotheses. The 'LYTEN' Trial

Josep Rodes-Cabau 2017. "Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprotheses. The 'LYTEN' Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03520101.

All > Aortic Stenosis